GETTIK HAIR REGROWTH TREATMENT- minoxidil 5% liquid

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 5.0% w/v
PURPOSE

Hair regrowth treatment for men
INDICATIONS & USAGE

To regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
WARNINGS
For external use only

For use by men only

Flammable: Keep away from fire or flame

Do not use if
- you are a woman
- your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Solution, 5% is not intended for frontal baldness or receding hairline.
- you have no family history of hair loss
- your hair loss is sudden and/or patchy
- you do not know the reason for your hair loss
- you are under 18 years of age. Do not use on babies and children.
- your scalp is red, inflamed, infected, irritated, or painful
- you use other medicines on the scalp
Ask a doctor before use if you have heart disease

When using this product
- do not apply on other parts of the body
- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- some people have experienced changes in hair color and/or texture
- it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
- the amount of hair regrowth is different for each person. This product will not work for all men.
Stop use and ask a doctor if
- chest pain, rapid heartbeat, faintness, or dizziness occurs
- sudden, unexplained weight gain occurs
- your hands or feet swell
- scalp irritation or redness occurs
- unwanted facial hair growth occurs
- you do not see hair regrowth in 4 months
May be harmful if used when pregnant or breast-feeding
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION
- apply one ML 2 times a day directly onto the scalp in the hair loss area
- using more or more often will not improve results
- continued use is necessary or hair loss will begin again
OTHER SAFETY INFORMATION
- see hair loss pictures on side of this carton
- before use read all information on carton and enclosed leaflet
- keep the carton, it contains important information
- hair growth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution 5%
- in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% provided more hair regrowth than Minoxidil Topical Solutions 2%
- store at controlled room temperature 20 degree to 25 degree C (68 degree to 77 degree F)
INACTIVE INGREDIENT

alcohol 30% v/v, propylene glycol 50% v/v, purified water
QUESTIONS

Questions: Call your health care professional or Gettik at 1-800-249-8095 or visit our website at https://gettik.com
PRINCIPAL DISPLAY PANEL

GETTIK HAIR REGROWTH TREATMENT
minoxidil 5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71700-112
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 71700-112-05	3 in 1 BOX	10/01/2017
1		60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074588	10/01/2017

Labeler - GETTIK International LLC (080820486)

GETTIK HAIR REGROWTH TREATMENT- minoxidil 5% liquid

GETTIK Hair Regrowth Treatment by

Drug Labeling and Warnings

Drug Details [pdf]